Single-Use filter capsules with constant, stable flow-rates providing efficient, high viral clearance and significantly-reduced processing costsWith the ever-present risk of virus contamination in biologic products, potential sources of virus contamination of biotechnology products include viruses associated with the cell lines (endogenous viruses), or viruses introduced into the bioreactor from culture medium or during the production processes (adventitious viruses).病毒还可能存在捐献的血浆衍生物中。
Kleenpak Nova Filter Capsules with Pegasus SV4 Virus Removal Filter Membrane are encapsulated, direct flow filters that combine robust, high viral clearance of parvovirus and larger viruses with high throughput capacity and stable flow rates, in both dilute and complex concentrated biological fluids.Consistent flow rates and high throughputs provide superior control of process performance and costs.The encapsulated format removes operating costs associated with traditional formats, such as cleaning and maintenance of filter housings, and cleaning validation.Capsules can be autoclaved and supplied as part of a single-use processing system such as a filter/tubing/biocontainer set.
|Incorporates Pegasus SV4 virus filter membrane||Offers robust, high parvovirus clearance (> 4 log reduction value)|
|Demonstrates constant, stable flow-rate performance||Improves process and cost control, enables maximum virus filtration economy and efficiency|
|Highly-resistant to filter ‘plugging’||Shows outstanding throughput capacity in both dilute and complex/concentrated biological fluids|
|High filter area per cartridge||Minimizes hold-up volume and system space requirements, reducing the Cost Of Goods Sold (COGS)|
|Automated in-situ integrity test both pre-use and post-use||Provides easy, reliable integrity testing, reducing labor costs and minimizing the risk of handling errors|
|Fully encapsulated format||Reduces operating costs, no cleaning validation required|
|In-line sanitization or autoclaving capability||Low bioburden for filtration of non-sterile intermediates without autoclaving.Highest aseptic safety with autoclaving where required|
|Suitable for inclusion in Allegro™ MVP systems for single-use, fully-automated virus filtration||Enables the highest level of process control and safety|
|项目||Material of Construction|
|膜||Hydrophilic modified polyvinylidenedifluoride (PVDF)|
|Support and Drainage Layers||聚酯|
|Core, Cage and Endcaps||聚丙烯|
|Housing Bowl and Head||聚丙烯|
|Recommended Operating Differential Pressure||2.1 to 3.1 bard (30 to 45 psid)|
|最大操作压力||5 barg (73 psig)|
|Maximum Differential Pressure||3.1 bard (45 psid) for continuous service, 6.2 bard (90 psid) during integrity testing only for up to a maximum of 10 hours|
|Autoclave||Maximum 125 °C, 2 x 1 hour cycles|
|Maximum Operating Temperature||40 °C (104 °F)|
* In compatible fluids that do not soften or swell, or adversely affect the filter or its materials of construction.For up to a maximum of 25 hours continuous service.
|孔径||20 nm (nominal)|
|Retention Ratings (Virus)||
> 4 log reduction value for
** Claims based on challenge with parvovirus model bacteriophage (bacterial virus) PP7
† > 4 log reduction value for bacteriophage PP7 per Parenteral Drug Association (PDA) Technical Report 41 rating method for small virus-retentive filters.> 4 log reduction value typically expected with mammalian parvoviruses
|Aqueous Extractables (NVR)||Refer to 颇尔 Publication USTR 2839|
|Filter Area (Nominal)||2.25 m2 (24 ft2) per 254 mm (10 in.) filter|
|Forward Flow Integrity Test||Diffusional flow integrity test, carried out by standard upstream or downstream methods|
Table 2Process Scale-Up with other Pegasus Grade SV4 Virus Filters
|过滤器类型||Part Number||Filter Area|
|颇尔 Minidisc Capsule||10MCFSV4||0.00096 m2|
|Filter Disc (47 mm)||FTKSV4047||0.0011 m2 (in FTK200 Holder)|
|Mini Kleenpak Capsule||KA02SV42FT***||0.058 m2|
|1 in.Kleenpak Nova Capsule||NP1LUSV4P16||0.25 m2|
|10 in.Filter Cartridge||AB1USV47PH4||2.25 m2|
|10 in.Kleenpak Nova Capsule (In-Line Style)||NP6LUSV47P1||2.25 m2|
|10 in.Kleenpak Nova Capsule(T-Style)||NT6USV47P1||2.25 m2|
Not all filter types can be steam-sterilized.Consult individual product datasheets for technical specifications.
This table shows the Pegasus SV4 product portfolio.Not all formats are available at the time of publication.
*** Filterability Tool version (FT).Not qualified for virus removal.For filterability tests only
High Parvovirus ClearancePegasus SV4 Virus Removal Filter membrane demonstrates highly-efficient clearance of both small ‘non-enveloped’ viruses as well as large viruses.Figure 1 provides an example of its high parvovirus clearance by showing the typical performance of a Pegasus SV4 filter in a 1 g.L-1BSA solution, as per the PDA’s guidelines:
图 1Retention of porcine parvovirus (PPV, n=4) and small spherical bacteriophage virus (PP7, n=9) by Pegasus Grade SV4 virus membrane in 1 g.L-1 BSA at 3.1 bar (45 psi)1
1 PPV retention testing was carried out at an independent virus validation test laboratory using 47 mm filter discs
Due to the high resistance to plugging and outstanding through - put properties of Pegasus SV4 membrane, typical viral spikes will not have significant impact on flux decay during viral retention studies.
Constant, Stable Flow-rate Performance, with Outstanding Throughput CapacityWith the need to control the Cost of Goods Sold now one of the main points of consideration in downstream processing, Pegasus SV4 Virus Removal Filter membrane has been designed to address this need by offering constant, stable flow rates and outstanding throughput capacity, thereby improving process and cost control and enabling maximum filtration economy and efficiency.
Highly-Efficient and EconomicalPegasus SV4 Virus Removal Filter Membrane also demonstrates highly-efficient clearance of both small ‘non-enveloped’ viruses and large viruses, providing constant flow rates with most biological fluids.It also offers stable pressure/flux capability with more complex or concentrated feeds, helping to improving virus filtration economy in highly-concentrated protein solutions.Figure 2 shows a typical flux profile for Pegasus SV4 Virus Removal Filter Membrane when challenged with monoclonal antibody solution.
图 2Results of Filterability Tests at 2.1 bar (30 psi) or 3.1 bar (45 psi) with up to 25 g.L-1 (2.5 %) MAb
* Performance predicted from tests performed on Pegasus SV4 Virus Removal Filter Discs (47 mm)
Reduces Processing CostsKleenpak Nova Filter Capsules with Pegasus SV4 Virus Removal Filter Membrane offer a very high filter area (2.25 m² per 10 in. filter) due to their unique, patented high area filter laid-over pleating construction which enables significantly more filter membrane to be packed into each capsule.This helps to maximize process productivity while minimizing process costs, by the amount of filter capsules required per installation, and helps minimize the hold up volume of the virus filter system.
图 3Laid-over pleat construction utilized by Kleenpak Nova Filter Capsules with Pegasus SV4 Virus Removal Filter Membrane
Superior Process Control and SafetyKleenpak Nova Filter Capsules with Pegasus SV4 Virus Removal Filter Membrane offer the highest level of process control and safety in process scale virus filtration.
Process Requirement:Aseptic SafetyBest practice – Kleenpak Nova Filter Capsules with Pegasus SV4 Virus Removal Membrane can be autoclaved and are suitable for inclusion into fully-automated Allegro™ MVP virus filter systems.
Process Requirement:Easy, Reliable Integrity TestingBest practice – Kleenpak Nova Filter Capsules with Pegasus SV4 Virus Removal Membrane can be in-situ integrity tested both pre-use and post-use.
Table 1Sterilization and Integrity Testing of Kleenpak Nova Filter Capsules with Pegasus SV4 Virus Removal Filters
|Steam In Place (SIP)||否|
|Autoclavable By User||是|
|Integrity Test Pre-Use||Yes (Non destructive, water-wet in situ)|
|Integrity Test Post-Use||Yes (Non destructive, water-wet in situ)|
Suitable for Inclusion in 颇尔’s Fully-automated Allegro MVP Single-use System颇尔 offers fully-automated Allegro MVP systems for virus filtration with a completely single-use fluid path, ensuring precise and consistent operation and improved process efficiency.The systems can be designed with automated integrity-test-in-place (ITIP) for the installed filter capsules, and ensure the highest level of manufacturing safety and process performance.
- Significant reductions in Cost of Goods
- Reduced labor, materials and facility operating costs
- No cleaning or cleaning validation required
- Ease of use and flexibility for different processes
- Increased productivity in manufacturing
- Better resource allocation
- Effective capacity utilization
- Robust operation and minimal risk of operator error
- Enables precise and consistent operation
- Built-in, non-destructive automated integrity-testing-in-place
图 4Fully-automated Allegro MVP Single-use System for Virus Filtration
图 5Kleenpak Nova Filter Capsules undergoing Integrity Testing
Rigorous Quality Testing at Multiple Stages of ProductionThroughout the process of manufacture of Kleenpak Nova Filter Capsules with Pegasus SV4 Virus Removal Membrane, 颇尔’s rigorous quality control systems ensure consistent performance as per the product specification.
- Quality Control at Multiple Production Stages
- 100 % fabrication integrity tested – correlated to PP7 bacteriophage removal
- Viral reduction tested with PP7 bacteriophage lot release test
- 100 % fabrication water flow tested
- Protein transmission tested
- Visual inspection control
Full Traceability, Fast and Efficient Data EntryEvery capsule is manufactured under a Quality Management System certified to ISO 9001:2008, and is identified by a part number with unique lot and serial numbers, to allow complete traceability of the product manufacturing history, and to assist the user’s own traceability systems.
High Quality StandardsThe filter components have met requirements for biological reactivity, in vivo, under USP <88> (for Class VI – 121 °C plastics) and in vitro, under USP <87> (Elution Test).
- Meets Cleanliness per USP <788> Particulate Matter in Injections
- Non-Fiber-Releasing per Title 21 of the U.S Code of Federal Regulations (CFR) parts 211.72 and 210.3 (b) (6)
- Non-Pyrogenic per USP <85> Bacterial Endotoxins Test
科学实验室服务颇尔’s Scientific and Laboratory Support (SLS) Global Technical Support group is available to provide you with the scientific and technical support you need to mitigate risk as part of your viral safety strategy.Our scientists have extensive experience in filtration and chromatographic methods, validating processes developed to prevent virus contamination, and developing standard operating procedures for the correct operation of virus removal technology in unit operations.Our experience also covers the necessary skills and expertise to appropriately document the entire approach, from test protocols that include scientific rationale related to methodology and sampling, to test execution including data analysis, followed by scientific report generation ready-prepared for regulatory submission.
|NP1LUSV4P1||Kleenpak Nova Filter Capsules with Pegasus SV4 Virus Removal Filter Membrane (In-Line Style)||
|NP6LUSV4Px||Kleenpak Nova Filter Capsules with Pegasus SV4 Virus Removal Filter Membrane (In-Line Style)||
|NP7LUSV4Px||Kleenpak Nova Filter Capsules with Pegasus SV4 Virus Removal Filter Membrane (In-Line Style)||
|NP8LUSV4Px||Kleenpak Nova Filter Capsules with Pegasus SV4 Virus Removal Filter Membrane (In-Line Style)||
|NT6USV4Px||Kleenpak Nova Filter Capsules with Pegasus SV4 Virus Removal Filter Membrane (T-Style)||
|NT7USV4Px||Kleenpak Nova Filter Capsules with Pegasus SV4 Virus Removal Filter Membrane (T-Style)||
|NT8USV4Px||Kleenpak Nova Filter Capsules with Pegasus SV4 Virus Removal Filter Membrane (T-Style)||
3 x = Add additional code for desired connection option, see ‘Connection Options’ table below.
|Connection Type||Applicable Product(s)||Code|
1 – 11⁄2 in. sanitary flange
inlet and outlet
|In-Line Style and T-Style||1|
|1 – 11⁄2 in. sanitary flange inlet and 13 mm (1⁄2 in.) single barb hose barb outlet||In-Line Style only||16|
|1 – 11⁄2 in. sanitary flange inlet and 25 mm (1 in.) single barb hose barb outlet||In-Line Style and T-Style||19|